Safety and Performance of a Hernia Blocking System

Disk Herniated Lumbar Clinical Trial

Official title:

A Multi-center, Prospective Study to Evaluate the Safety and Performance of a Hernia Blocking System to Prevent Recurrent Lumbar Disc Herniation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188236
• Other study ID #: NEO-RA1-2018-01
• Status: Completed
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: June 26, 2023

Study information

• Verified date: October 2023
• Source: NEOS Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject is between 18 and 75 years of age.
• Posterolateral disc herniation at one level between L4 and S1 with radiographic confirmation (CT and/or MRI) of neural compression.
• At least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.
• Minimum posterior disc height of 5 mm at the index level.
• Radiculopathy with positive straight leg raise test.
• ODI score of at least 40/100.
• Subjects who are able to give voluntary informed consent to participate in the clinical investigation and from whom consent has been obtained.
• Subject is able and willing to comply with the protocol requirements.

Exclusion Criteria:

• Spondylolisthesis and/or instability at the index level.
• Foraminal, extra-foraminal or central disc herniation.
• Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
• Subject has scoliosis of greater than 20 degrees (both angular and rotational).
• Less than 20 mm of interpedicular distance in the spinal canal at the index level.
• Grossly distorted anatomy due to congenital abnormalities.
• Deformation that affect the posterior corners of the vertebra at the index level (e.g., osteophytes).
• Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation.
• Prior surgery at the index lumbar vertebral level.
• Radiological confirmation of severe facet joint disease or degeneration.
• Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry DXA T-score of less than -2.0 at the index level.
• Cauda equina syndrome.
• Fever, leucocytosis and/or systemic or localized active infection.
• Systemic inflammation and/or inflammation at the implantation site.
• Any metabolic bone disease.
• Insulin-dependent diabetes mellitus.
• Peripheral neuropathy.
• Active hepatitis, AIDS or HIV.
• Rheumatoid arthritis or other autoimmune disease.
• Active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible.
• Active tuberculosis or history of tuberculosis in the past 3 years.
• Immunologically suppressed patients.
• Current anticoagulation therapy, unless anticoagulation therapy can be suspended for surgery.
• Patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index surgery.
• Suspected or known allergies or intolerance to the implant materials.
• Any condition that precludes the use of general anesthesia.
• Any condition that precludes the surgical procedure.
• Any contraindication for MRI or CT scan.
• Class III obesity: Body mass index = 40.
• Current alcohol or recreational drug dependency.
• Pregnant or interested in becoming pregnant in the following 24 months.
• Breastfeeding.
• Life expectancy less than 2 years.
• Subject is currently participating or has participated in the previous 4 weeks in any other interventional clinical study.

Related Conditions & MeSH terms

• Disk Herniated Lumbar
• Hernia

Intervention

Device:
• Hernia Blocking System
Hernia Blocking System device implanted during a lumbar discectomy procedure

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital QuirónSalud Barcelona	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitario de Canarias	La Laguna
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
NEOS Surgery

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically symptomatic recurrent lumbar disc herniation		24 months
Secondary	The incidence and type of all adverse events (AE) and serious adverse events (SAE).		6 weeks, 6 months, 12 months, and 24 months
Secondary	Incidence of clinically asymptomatic recurrent disc herniation		6 months, 12 months, and 24 months
Secondary	Disc height maintenance [mm] related to baseline		6 weeks, 6 months, 12 months, and 24 months
Secondary	Change in leg and low back pain assessed by NRS (numeric rating scale), related to baseline	0-10 NRS	6 weeks, 6 months, 12 months, and 24 months
Secondary	Change in Low back related disability according to the Oswestry Disability Index (ODI), related to baseline		6 weeks, 6 months, 12 months, and 24 months
Secondary	The change in quality of life according to EQ-5D-5L, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
Secondary	The change in the patient work status, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
Secondary	The change in patient neurological status: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
Secondary	The change in the kinematics of the intervertebral disc at the index level, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
Secondary	The change in the disc degeneration (Pfirrmann scale), compared to baseline		6 months, 12 months, and 24 months
Secondary	The change in the endplate lesions (MODIC scale), compared to baseline		6 months, 12 months, and 24 months